MAUDE Adverse Event Report: TANDEM DIABETES CARE T:FLEX INSULIN DELIVERY SYSTEM; INFUSION PUMP

Model Number	004628-005
Medical Device Problem Codes	Overheating of Device (1437); Battery Problem (2885); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.H3 other text : device not returned.
Event or Problem Description
It was reported that the pump battery was depleting quickly and that the wake button was sticking.Additionally, it was reported that the pump was warm to the touch despite being in room-temperature conditions.Reportedly, the pump was charging during the event.There was no reported adverse impact to the customer¿s blood glucose level.The customer declined follow-up troubleshooting with tandem technical support, therefore no additional information could be obtained.

• Brand Name: T:FLEX INSULIN DELIVERY SYSTEM
• Common Device Name: INFUSION PUMP
• Manufacturer (Section D): TANDEM DIABETES CARE; 12400 high bluff drive; san diego CA 92130
• Manufacturer Contact: michael trier ; san diego, CA 92130 ; 8584011451
• MDR Report Key: 17326379
• Report Number: 3013756811-2023-98184
• Device Sequence Number: 5642005
• Product Code: LZG
• UDI-Device Identifier: 00852162004385
• UDI-Public: (01)00852162004385
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K143189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 004628-005
• Device Catalogue Number: 005365
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic